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Miacalcin Nasal (Calcitonin (Salmon) Nasal) - Summary

 
 



SUMMARY

Calcitonin is a polypeptide hormone secreted by the parafollicular cells of the thyroid gland in mammals and by the ultimobranchial gland of birds and fish.

Miacalcin® (calcitonin-salmon) Nasal Spray is indicated for the treatment of postmenopausal osteoporosis in females greater than 5 years postmenopause with low bone mass relative to healthy premenopausal females. Miacalcin® Nasal Spray should be reserved for patients who refuse or cannot tolerate estrogens or in whom estrogens are contraindicated. Use of Miacalcin® (calcitonin-salmon) Nasal Spray is recommended in conjunction with an adequate calcium (at least 1000 mg elemental calcium per day) and vitamin D (400 I.U. per day) intake to retard the progressive loss of bone mass. The evidence of efficacy is based on increases in spinal bone mineral density observed in clinical trials.
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NEWS HIGHLIGHTS

Published Studies Related to Miacalcin Nasal (Calcitonin Nasal)

Efficacy and harms of nasal calcitonin in improving bone density in young patients with inflammatory bowel disease: a randomized, placebo-controlled, double-blind trial. [2011.08]
OBJECTIVES: There are very few published studies of agents having the potential to improve bone health in children with inflammatory bowel disease (IBD). The objective of this study was to establish the efficacy and safety of intranasal calcitonin in improving bone mineral density (BMD) in young patients with IBD and to define additional factors that impact bone mineral accrual... CONCLUSIONS: Intranasal calcitonin is well tolerated but does not offer a long-term advantage in youth with IBD and decreased BMD. Bone mineral accrual rate remains compromised in youth with IBD and low BMD raising concerns for long-term bone health outcomes. Improvement in nutritional status, catch-up linear growth, control of inflammation, increase in weight-bearing activity, and lower daily caffeine intake may be helpful in restoring bone density in children with IBD and low BMD.

Optimizing bioavailability of oral administration of small peptides through pharmacokinetic and pharmacodynamic parameters: the effect of water and timing of meal intake on oral delivery of Salmon Calcitonin. [2008.09.09]
BACKGROUND: To investigate the influence of water intake and dose timing on the pharmacokinetic and pharmacodynamic parameters of an oral formulation of salmon calcitonin (sCT)... CONCLUSION: 0.8 mg sCT with 50 ml of water taken 30 and 60 minutes prior to meal time resulted in optimal pharmacodynamic and pharmacokinetic parameters. The data suggest that this novel oral formulation may have improved absorption and reduction of bone resorption compared to that of the nasal form.

A randomized double-blind placebo-controlled trial to investigate the effects of nasal calcitonin on bone microarchitecture measured by high-resolution peripheral quantitative computerized tomography in postmenopausal women - Study protocol. [2008.04.13]
ABSTRACT: BACKGROUND: Bone microarchitecture is a significant determinant of bone strength.We hypothezise that - compared to placebo - calcitonin impacts on microstructural parameters, with a possible difference between weight bearing and non-weight bearing bones.

Comparison of calcitonin versus calcitonin + resistance exercise as prophylaxis for osteoporosis in heart transplant recipients. [2006.04.27]
BACKGROUND: Rapid bone loss occurs early after heart transplantation. There is no standard therapeutic intervention to prevent osteoporosis in heart transplant recipients (HTR). The purpose of this study was to determine the effectiveness of a regimen combining the antiresorptive properties of nasal calcitonin with the osteogenic stimulus of resistance exercise... CONCLUSIONS: Calcitonin attenuates BMD loss in the total body and femur neck but not in trabecular bone of the lumbar vertebra. Mechanical loading, through progressive resistance exercise, is an osteogenic stimulus in HTR.

The effectiveness of calcitonin on chronic back pain and daily activities in postmenopausal women with osteoporosis. [2006.03]
The aim of this study was to investigate the effect of nasal calcitonin on chronic back pain and disability attributed to osteoporosis. The study design involved three groups of osteoporotic postmenopausal women suffering from chronic back pain... Intranasal calcitonin has no effect on chronic back pain intensity and functional capacity of osteoporotic women regardless of the presence of fractures, degenerative disorders or chronic back pain of non-specific etiology.

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Clinical Trials Related to Miacalcin Nasal (Calcitonin Nasal)

Calcitonin for Treating X-linked Hypophosphatemia [Recruiting]
X-linked hypophosphatemia (XLH) is the most common form of inherited rickets in the United States. It also causes bone disease in adults. XLH is caused by overproduction of a hormone call FGF23, which makes the body waste phosphate. This study is designed to determine if nasal calcitonin, an already approved drug in the US, can lower blood levels of FGF23 and reduce phosphate wasting in patients with XLH. In this study the investigators will:

1. Determine whether nasal calcitonin significantly lowers integrated 24-hour blood levels of FGF23 in patients with XLH.

2. Evaluate whether nasal calcitonin improves serum phosphate levels in XLH.

3. Assess whether nasal calcitonin improves blood levels of the active form of vitamin D and calcium absorption from the intestine.

4. Make sure that nasal calcitonin is safe and well tolerated.

FGF-23 Suppressibility by Calcitonin [Recruiting]
Introduction:

Based on our experience with calcitonin as an FGF-23 suppressive agent in a patient with an FGF-23 producing tumor we hypothesize that calcitonin may be a physiologically important regulator of FGF-23 production and secretion in healthy humans.

Aim:

In this study we wish to examine the FGF-23 suppressive effects of calcitonin in healthy men.

Study Design:

placebo-controlled, cross-over study

Method:

- All twelve subjects are examined on two occasions, once after exposure to placebo 1 ml

NaCl 0. 9% subcutaneously, and once following calcitonin 200 IU/ml subcutaneously

- On both occasions frequent bloodsampling will take place, out an indwelling catheter in

de forearm vein.

- Sampling times: -15, 0, 60, 120, 240, 360, and 480 minutes

- Mealtimes: Calcium and Phosphate intake standardized on both occasions

- All samples are analyzed for FGF-23, using a C-terminal FGF-23 ELISA kit (Immunotopics,

San Clemente, USA) that measures intact and C-terminal fragments of FGF-23, and one that measures only intact FGF-23

- Samples obtained at T-15, T0, T240 and T480 are stored for later analysis of Ca,

albumin, PO4, PTH, 25-OHD and 1,25-OHD

Endpoint:

A change of 25% in de serum FGF-23 levels in response to a single subcutaneous injection of calcitonin 200 IU.

Effects of Water and Food Intake on the Pharmacokinetics and Pharmacodynamics of Oral Salmon Calcitonin in Healthy Postmenopausal Women [Completed]
This is a phase I study to analyze the effect of water and food intake on the bioavailability and pharmacodynamic of oral salmon calcitonin (SMC021) and salmon calcitonin nasal spray in post-menopausal women.

Pharmacokinetics/Pharmacodynamics of Oral Salmon Calcitonin in Patients With Osteoarthritis [Completed]
The purpose of this study is to expose patients with OA to calcitonin and to determine plasma calcitonin levels after administration of 0. 6 mg and 0. 8 mg oral calcitonin and 200 IU nasal calcitonin. Also the purpose is to assess the effect of different doses of oral calcitonin (0. 6 mg and 0. 8 mg oral) and 200 IU nasal calcitonin compared to placebo on serum CTX-I and CTX-II. Finally to assess the tolerance profile of different doses/formulations of oral calcitonin compared to placebo.

Efficacy and Safety of Salmon Calcitonin Nasal Spray in Improving Muscle Strength and Reducing Pain After Forearm Fracture in Postmenopausal Women [Completed]
Calcitonin has been used for many years for treating osteoporosis in postmenopausal women, and it has been shown that calcitonin reduces pain after spine and hip fracture in women with osteoporosis. Therefore, this study assesses the safety and efficacy of salmon calcitonin nasal spray on muscle strength after a forearm fracture, pain, quality of life and fracture healing in postmenopausal women.

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Page last updated: 2011-12-09

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